Proliferative Diabetic RetinopathyPhase 2ELYSIANNCT02630277
Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept injectioN
A Phase 2 study testing Aflibercept in people with Proliferative Diabetic Retinopathy, run by Valley Retina Institute.
Trial summary
To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR. To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:
- Any neovascularization of the disc (NVD) + vitreous hemorrhage
- Mild neovascularization of the disc (NVD) of at least 1/2 to 1/3 disc area as shown in standard photograph 10A of the DRS
- Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS + vitreous hemorrhage2. Patient's study eye must be treatment naïve; no history of intravitreal anti-angiogenic treatment, intravitreal steroid treatment, or any laser treatment to study eye
- 18 years or older males and females with a history of diabetes mellitus and ability to sign informed consent
- ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit
- Eyes with mild pre-retinal hemorrhage or mild vitreous hemorrhage that does not interfere with clear visualization of the macula and optic disc are eligible for this study
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc
- Presence of either:
- Significant epiretinal membranes involving the macula, or
- Proliferative diabetic membranes along the major retinal arcades that are extensive enough to cause either:
- Significant vitreomacular traction or
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- Significant impairment in visual acuity
- Presence of any tractional retinal detachment
- Severe ischemia involving the foveal avascular zone (≥1 disc area) as determined by fluorescein angiography performed at the initial screening visit
- Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc
- Presence of neovascular glaucoma with or without hyphema
- Previous treatment with intravitreal steroid injections in the study eye
- Previous treatment with topical anti-inflammatory medications in the study eye
- Previous treatment with peribulbar steroid injections in the study eye
- Previous PRP/focal laser treatment in the study eye
- History of vitreoretinal surgery in the study eye
- Previous treatment with anti-angiogenic drugs in either eye
- History of idiopathic or autoimmune uveitis in either eye
- Active ocular inflammation (including trace or above) in the study eye
- Structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, or organized hard-exudate plaque
- Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or CNVM of any cause
- Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
- Cataract surgery in the study eye, yttrium-aluminum-garnet (YAG) laser capsulotomy, or any other intraocular surgery
- Aphakia or absence of the posterior capsule in the study
- Uncontrolled glaucoma or previous filtration surgery in the study eye
- Evidence at examination of infectious blepharitis, keratitis, scleritis or conjunctivitis in either eye or current treatment for serious systemic infection
- History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 1
- Participation in an investigational trial within 30 days prior to screening that involved treatment with any drug (excluding vitamins and minerals) or device
- Pregnancy (positive pregnancy test) or lactation Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept Injection (ELYSIAN)
To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR.
To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR
Read the detailed description
This study will evaluate two dosing regimens (monthly and PRN following a loading dose) for treatment of PDR with intravitreal aflibercept injection. Additionally, the study will identify biomarker mediators in vitreous fluid present at baseline in patients with PDR and will track over the course of a year their profile changes in response to these two dosing regimens. The treatment regimens will provide information on the biomarker profile with a monthly regimen as well as with a variable regimen. Furthermore, biomarker mediators that may be associated with anti-VEGF responders and non-responders may also be identified. 105 biomarker mediators (cytokines/chemokines) which have been identified as playing a role in PDR in published studies will be profiled in patients with PDR.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Aflibercept
- Keywords
- Proliferative Diabetic Retinopathy, High Risk PDR, aflibercept, regression of retinal neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea
Intravitreal Aflibercept Injection 2.0 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 1:1 Intravitreal Aflibercept Injection once every 4 weeks Receives: Drug: Aflibercept |
| Arm 2 | Experimental | Intravitreal of Aflibercept once every 4 weeks for 4 months then as needed (PRN) Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess ocular and non-ocular adverse events
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valley Retina Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor H Gonzalez, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630277
- Sponsor's protocol ID
- ELYSIAN
- Acronym
- ELYSIAN
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept Injection (ELYSIAN)
- ClinicalTrials.gov ID
- NCT02630277
- Acronym / sponsor ID
- ELYSIAN / ELYSIAN
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative Diabetic Retinopathy, High Risk PDR, aflibercept, regression of retinal neovascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Valley Retina InstituteUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR.
To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR
Detailed description
This study will evaluate two dosing regimens (monthly and PRN following a loading dose) for treatment of PDR with intravitreal aflibercept injection. Additionally, the study will identify biomarker mediators in vitreous fluid present at baseline in patients with PDR and will track over the course of a year their profile changes in response to these two dosing regimens. The treatment regimens will provide information on the biomarker profile with a monthly regimen as well as with a variable regimen. Furthermore, biomarker mediators that may be associated with anti-VEGF responders and non-responders may also be identified. 105 biomarker mediators (cytokines/chemokines) which have been identified as playing a role in PDR in published studies will be profiled in patients with PDR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Aflibercept1:1 Intravitreal Aflibercept Injection once every 4 weeks |
| Arm 2 | Experimental | Drug: AfliberceptIntravitreal of Aflibercept once every 4 weeks for 4 months then as needed (PRN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:
- 18 years or older males and females with a history of diabetes mellitus and ability to sign informed consent
- ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit
- Eyes with mild pre-retinal hemorrhage or mild vitreous hemorrhage that does not interfere with clear visualization of the macula and optic disc are eligible for this study
Key exclusion criteria (29 listed)
- Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc
- Presence of either:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptAlso: EyleaIntravitreal Aflibercept Injection 2.0 mg | Drug | Arm 1, Arm 2 |
Primary outcome
Assess ocular and non-ocular adverse events
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor H Gonzalez, MD principal investigator
Medical Director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept in people with Proliferative Diabetic Retinopathy, run by Valley Retina Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor H. Gonzalez, MD (956-631-8875 ext. 118, research@vritx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess ocular and non-ocular adverse events (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.